Stress urinary incontinence (“SUI”) is a widespread problem throughout the world affecting people of all ages and gender. SUI is the involuntary leakage of small amounts of urine resulting from an increased pressure in the abdomen and may result while sneezing, coughing, laughing, bending, lifting, etc. While primarily a female problem, men also suffer from stress urinary incontinence, and rates of male SUI are increasing along with the increased use of prostate surgery. Stress incontinence in men is typically the result of a weakened urethral sphincter that surrounds the prostate, frequently as a result of prostate surgery.
For treating SUI, it is often necessary to resort to surgery. Conventional techniques consist of restoring the natural mechanisms of continence, maintaining the urethra in the abdominal cavity, and/or increasing urethral resistance. To do this, a conventional sling is placed under the urethra, thereby making it possible to improve the suspension and provide some compression of the urethra. Currently, there are a variety of different sling procedures which differ in the anchoring methods and materials used.
Despite advances in midurethral sling design over the past years, there still remains considerable room for improvements, particularly in sling design and placement. For example, such procedures typically require hospitalization. Thus, many females and males with stress urinary incontinence avoid or delay undergoing an operation. Moreover, although serious complications associated with sling procedures are infrequent, they do occur. In some cases, the slings cause friction in the area of the vagina or urethra during the patient's movements and may injure different organs with which they are in contact. This friction may then cause erosion, inflammation or infection, or even cause rejection of the sling, thereby requiring another operation to surgically remove the sling.
Other shortcomings of known sling designs include the fact that multiple incisions are typically required to implant a sling, thereby increasing the patient's level of discomfort and recovery time. Additionally, passage of mesh through the skin or subcutaneous tissue can result in patient discomfort and therefore most commonly requires general anesthesia. Moreover, once implanted, the sling cannot be adjusted, and thus if the sling is not implanted in the precise or ideal location, the patient may continue to have incontinence-related issues. There are some devices whose use compromises the surgeon's ability to easily and accurately tension the sling. This is being perceived as a major shortcoming, and is probably a major reason underlying unacceptable initial failure rates of approximately 25%.
Accordingly, there exists a need for a sling that satisfactorily treats stress urinary incontinence and that permits post-operative adjustment of the sling. Further needs exist for methods for implanting slings that minimize a subject's discomfort and recovery time and allow for placement under local anesthesia.